Atenolol

Product NDC
53002-4108
11-digit product format
530024108
Labeler code
53002
Product ID
53002-4108_c689a7bc-40a4-44ca-ba3b-707b0423a998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077443
Marketing category
ANDA
Marketing start
2010-06-10
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4108-0Atenolol100 in 1 BOTTLETABLET1001
53002-4108-3Atenolol30 in 1 BOTTLETABLET301
53002-4108-6Atenolol60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4108ATENOLOL TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_678fc540-33b1-4549-a10d-3bc90c6ecf1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN678fc540-33b1-4549-a10d-3bc90c6ecf1b1
197380atenolol 25 MG Oral TabletSCD678fc540-33b1-4549-a10d-3bc90c6ecf1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4108-053002410800100 TABLET in 1 BOTTLE (53002-4108-0) 100 tablet2021-01-010000-00-00NoNoCurrent
53002-4108-35300241080330 TABLET in 1 BOTTLE (53002-4108-3) 30 tablet2021-01-010000-00-00NoNoCurrent
53002-4108-65300241080660 TABLET in 1 BOTTLE (53002-4108-6) 60 tablet2021-01-010000-00-00NoNoCurrent